The Use of Ossein-hydroxyapatite Complex as an Adjunctive Treatment in Orthopedics and Traumatology
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- period of bone union
研究概览
简要总结
The aim of this study was to evaluate the supportive effect of the ossein-hydroxyapatite complex in fracture healing. The investigators hypothesized that the ossein-hydroxyapatite complex would positively impact fracture healing outcomes.The assessment covers clinical, radiological and biomechanical parameters.
详细描述
The role of ossein-hydroxyapatite complex in fracture healing requires further research.
The aim of the study was to evaluate the effect of ossein-hydroxyapatite complex (Osteogenon) as an adjunctive treatment on the outcome of conservative and surgical fractures treatment via comprehensive clinical, radiological and biomechanical assessments. The investigators aimed to reject the null hypothesis of the absence of beneficial effect of ossein-hydroxyapatite complex on fractures treatment outcomes. This would fill the existing gap in the scientific literature and enable a more widespread use of Osteogenon in the treatment of fractures in many trauma centers.
Patients in the study group with fractures received an ossein-hydroxyapatite complex (830 milligram [mg] of ossein-and-hydroxyapatite complex, with 444 mg of hydroxyapatite, equivalent to 178 mg of calcium and 82 mg of phosphorus) throughout the entire period following fracture healing. The tablets were taken orally, one tablet twice daily.
The drug Osteogenon used in our study had been approved for fracture treatment. The study was conducted in accordance with the Declaration of Helsinki and all applicable laws and regulations. All patients had provided their written informed consent and were informed of a voluntary nature of their participation in this study.
Patients participating in the study, both in the study and control groups, had to meet the inclusion criteria. The randomization method used was to evenly recruit the study and control groups as patients who met the inclusion criteria were recruited. Randomization took into account the equal distribution of gender and age in both groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •no contraindications to taking Osteogenon
- •a follow-up period of more than 3 months after treatment completion
- •complete medical and radiological records
- •a written informed consent
- •not taking any other medications that could affect bone tissue remodeling
- •not taking other medications that interact with Osteogenon
- •no other limb pathologies (inflammatory or neurogenic)
- •absence of comorbidities that could affect bone union
排除标准
- •age under 18 years or over 85 years
- •hypersensitivity to the active ingredient or to any of the excipients
- •severe renal failure and dialysis therapy
- •hypercalcemia
- •hypercalciuria
- •calcium-based kidney stones or tissue calcifications
- •a follow-up period shorter than 3 months after treatment completion
- •a lack of informed consent
- •a lack of cooperation with the patient
- •absent or incomplete medical and radiological records
- •taking medications that could affect bone tissue remodeling
- •taking medications that may interact with Osteogenon (e.g. thiazide diuretics)
- •metabolic disorders
- •post-traumatic skeletal deformities
- •neuromuscular disorders
- •post-inflammatory deformities
研究组 & 干预措施
Osteogenon
received an ossein-hydroxyapatite complex
干预措施: received an ossein-hydroxyapatite complex (Drug)
结局指标
主要结局
period of bone union
时间窗: at 6 months after randomisation
assessed by data linkage to medical and radiological records
Achieving bone union
时间窗: at 6 months after randomisation
assessed by data linkage to medical and radiological records
次要结局
- pain assessment(at 6 months after randomisation)
研究者
Piotr Morasiewicz
Professor
University of Opole
